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U.S. Department of Health and Human Services

Safety

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September 2012

Drug Safety Labeling Changes

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

PCI=PATIENT COUNSELING INFORMATION

 
     
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Exjade (deferasirox) Tablets 
X
XXXX 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Accupril (quinapril hydrochloride) 5 mg, 10 mg, 20 mg and 40 mg Tablets

*Dual Blockade of the RAS

 X   

Accuretic (quinapril HCL/hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg and 20/25 mg Tablets

*Dual Blockade of the RAS

 X X  
Arcapta Neohaler (indacaterol maleate) Inhalation Powder 75 mcg XXXXMG

Avapro (irbesartan) 75 mg, 150 mg, and 300 mg tablets

*Dual Blockade of the RAS

 X X  

Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg Tablets

*Dual Blockade of the RAS

 X X  

Benicar (olmesartan medoxomil) 5 mg 20 mg and 40 mg Tablets

*Dual Blockade of the RAS

 X X  

Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg and 40/25 mg Tablets

*Dual Blockade of the RAS

 X X  

Cozaar (losartan potassium) 25 mg, 50 mg and 100 mg Tablets

*Dual Blockade of the RAS

 X X  
Doxil (doxorubicin HCl liposome injection) for intravenous infusion, single dose vial: 20 mg/10 mL and 50 mg/25 mL  X    
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets XXXXPPI
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets XXXXPCI

Hyzaar (losartan potassium/HCTZ) 50/12.5 mg, 100/25 mg, and 100/12.5 mg Tablets

*Dual Blockade of the RAS

 X  X  
Juvisync (sitagliptin/simvastatin) Tablets, 100mg/10mg, 100 mg/20 mg, 100mg/40mg, 50mg/10mg, 50 mg/20 mg, and 50mg/40mg XXXXMG

Lotensin (benazepril HCl) 5 mg, 10 mg 20 mg and 40 mg Tablets

*Dual Blockade of the RAS

 X X  

Lotensin HCT (benazepril HCl and hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg 20/12.5 mg and 20/25 mg Tablets

*Dual Blockade of the RAS

 X X  

Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets

*Dual Blockade of the RAS

 X X  
Multaq (dronedarone hydrochloride) 400 mg Tablets  XXMG
Ozurdex (dexamethasone intravitreal implant) 0.7 mg     

Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg, and 4/240 mg Tablets

*Dual Blockade of the RAS

 X X  

Teveten (Eprosartan Mesylate) 400 mg and 600 mg Tablets

*Dual Blockade of the RAS

 X X  

Teveten HCT (eprosartan mesylate hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets

*Dual Blockade of the RAS

 X X  

Tribenzor (olmesartan medoxomil amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg 40/10/12.5 and 40/10/25 mg Tablets

*Dual Blockade of the RAS

 X X  

Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets

*Dual Blockade of the RAS

 X X  

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets

*Dual Blockade of the RAS

 X X  

Vasotec (enalapril maleate) 2.5 mg, 5 mg, 10 mg, and 20 mg Tablets 

*Dual Blockade of the RAS

  X  

Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets
 

*Dual Blockade of the RAS

 X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 milligram vial  XXXPCI
Aggrenox (aspirin/extended release dipyridamole) 25 mg/200 mg Capsules   XX 
Cefepime for Injection USP and Dextrose Injection USP in the Duplex Container
Cefepime Injection in the GALAXY Container for intravenous use
 
  XX 

Dexilant (dexlansoprazole) Delayed-release Capsules

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  X  
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg   XMG
Lovaza (omega 3-acid ethyl esters) Capsules  XX PPI
Maxipime (cefepime hydrochloride) for Injection  XXX 

Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg
 

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  XX  

Nexium I.V. (esomeprazole sodium) For Injection

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  XX  

Prevacid (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg and Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  XX  

Prilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 2.5 mg and 10 mg

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  XX  

Protonix (pantoprazole sodium) For Injection

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  XX  
Rotarix (Rotavirus Vaccine, Live, Oral)  XXX 
Trilipix (fenofibric acid) Delayed Release Capsules   XXX 

Vimovo (naproxen/esomeprazole magnesium) Delayed Release Tablets

*Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)

  XX  
Xgeva (denosumab)  XX  
Xyzal (levocetirizine dihydrochloride) 5mg tablets and 2.5mg/5ml solution   XXPCI
Zomig (zolmitriptan) tablets
Zomig-ZMT (zolmitriptan) orally disintegrating tablets
  XX  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Glyset (miglitol) Tablets, 25 mg, 50 mg and 100 mg    X 
Voltaren Opthalmic (diclofenac sodium ophthalmic solution) 0.1%    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Cayston (aztreonam for inhalation solution)     
X
 
Singulair (Montelukast Sodium) 10 mg Tablets, 5 mg and 4 mg Chewable Tablets, and 4mg Oral Granules     X 
Tradjenta (linagliptin) tablets, 5 mg    X 
Ventolin HFA (albuterol sulfate) Inhalation Aerosol    X 
Xopenex (levalbuterol HCl) Inhalation Solution Concentrate, 1.25 mg/0.5 mL    X 
Zytiga (abiraterone acetate) Tablets    X 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AndroGel (testosterone gel) 1.62%      MG
CellCept (mycophenolate mofetil) Capsules, Tablets, Oral Suspension and CellCept (mycophenolate mofetil hydrochloride) for Injection     MG
Clobex (clobetasol propionate) Spray, 0.05%      PPI
Micardis (telmisartan) 20, 40, and 80 mg Tablets     PPI
Myfortic (mycophenolic acid) delayed-release tablets     MG
Prolia (denosumab)     MG